Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- visual analog scale (VAS)
研究概览
简要总结
This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus
详细描述
Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent
排除标准
- •Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate
研究组 & 干预措施
Control group
Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.
干预措施: Topical pomegranate seeds and peel extracts (Drug)
Group S
Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.
干预措施: Topical pomegranate seeds and peel extracts (Drug)
Group P
Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.
干预措施: Topical pomegranate seeds and peel extracts (Drug)
结局指标
主要结局
visual analog scale (VAS)
时间窗: 4 weeks
Pain assessment scale
次要结局
- OHIP-14 questionnaire(4 weeks)
- Sign score(4 weeks)
研究者
Mai Zakaria Ibrahium Mohammed
Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt
Cairo University